Antineoplastic Combined Chemotherapy Protocols, Peripheral Neuropathy
Conditions
Keywords
Chemotherapy-induced, neuropathy, cancer
Brief summary
This study was designed to evaluate the safety and efficacy of Cesamet™ in controlling pain in subjects experiencing pain due to chemotherapy-induced neuropathic pain in patients with cancer.
Detailed description
To determine the safety and efficacy of Cesamet™ in the symptomatic treatment of chemotherapy-induced neuropathic pain. This is a phase IV, multicenter, open label of Cesamet™ at 1 mg daily progressing to 2mg BID in subjects with chemotherapy-induced neuropathic pain. This study has two phases: A pretreatment phase and a treatment phase.
Interventions
Sponsors
NEMA Research, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with chemotherapy-induced neuropathic pain. * Chronic daily pain present for at least 2 months. * On stable analgesic regimen for one month. * Baseline pain score greater than 40mm on a VAS.
Exclusion criteria
* Hypersensitivity to compounds in study drug or similar drugs * Pregnant or lactating females * Drug or alcohol abuse * Unstable medical condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Average Pain Score at target site. | — |
Secondary
| Measure | Time frame |
|---|---|
| The Worst Pain Score at target site. | — |
| The Pain at Night Score at target site. | — |
| Quality of Life measures. | — |
| Patient satisfaction with treatment. | — |
| Safety will be assessed through the collection of AEs and vital signs. | — |
Countries
United States
Outcome results
None listed